MAUDE Adverse Event Report: CORDIS US CORP. SMART CONTROL ILIAC; STENT, ILIAC

Catalog Number C10060SL

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a smart control, iliac 10mm x60mm self-expanding stent (ses) was attempted to be implanted at the iliac artery by cross-over approach; however, the complaint device was unable to cross the lesion.Pre dilation was performed several times and re-insertion was done but the complaint device was unable to cross the lesion due to tortuosity.The physician used a stiff unknown wire as well, but the complaint device was unable to cross the lesion and the tip got cracked.The use of the complaint device was stopped, and the procedure terminated in percutaneous old balloon angioplasty (poba) only.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

A smart control, iliac 10mm x60mm self-expanding stent (ses) was attempted to be implanted at the iliac artery by cross-over approach; however, the complaint device was unable to cross the lesion.Pre dilation was performed several times and re-insertion was done but the complaint device was unable to cross the lesion due to tortuosity.The physician used a stiff unknown wire as well, but the complaint device was unable to cross the lesion and the tip got cracked.The use of the complaint device was stopped, and the procedure terminated in percutaneous old balloon angioplasty (poba) only.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 18103050 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis the reported ¿stent delivery system (sds)-ses~ failure to cross¿ and ¿catheter tip~ cracked¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics may have contributed to the reported events.According to the instructions for use (ifu) ¿system handling ¿ precautions.Do not use if it appears to be damaged.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17153496
• MDR Text Key: 318196925
• Report Number: 9616099-2023-06525
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: C10060SL
• Device Lot Number: 18103050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1